Associate Director of Analytical Development
14 hours ago
We are seeking a highly skilled and experienced Associate Director to lead our Analytical Development team. As a key member of our Strategic External Development organization, you will be responsible for developing, manufacturing, and characterizing drug substances and drug products.
Key Responsibilities- Lead a team of analytical scientists in the development, manufacturing, and release of drug substances and drug products.
- Develop and execute strategies for analytical development, including process characterization and product quality assessment.
- Collaborate with cross-functional teams to ensure strong process and product development and characterization.
- Author, review, and approve key source documents for regulatory filings.
- Lead and track analytical development commitments to support CMC filing activities.
- M.S. or Ph.D. degree in analytical chemistry, chemistry, or chemical engineering with pharmaceutical industry experience.
- 10 or more years of analytical development experience, including 3 or more years of people management and analytical project leadership experience.
- 5 or more years of experience in analytical assay development, qualification, and validation.
- 2 or more years of experience in methods tech transfer and life cycle management.
- Exposure to all stages of drug development.
- Proven ability to manage projects and work with cross-functional teams.
- Experience with mRNA, peptides, and conjugated biologic therapeutics modalities.
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
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Associate Director of Analytical Development
4 days ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleGSK is seeking a highly skilled and experienced Associate Director of Analytical Development to join our team. As a key member of our organization, you will be responsible for leading a team of analytical scientists and ensuring the development, manufacturing, release, and stability testing of drug substances and drug products.Key...
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Associate Director of Analytical Development
4 days ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director of Analytical Development to join our team at GlaxoSmithKline. As a key member of our organization, you will be responsible for leading a team of analytical scientists and ensuring the development, manufacturing, release, and stability testing of drug substances and drug...
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Senior Analytical Development Scientist
2 weeks ago
Waltham, Massachusetts, United States Alkermes Full timeJob SummaryThe Associate Principal Scientist position within Analytical Development at Alkermes leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. This role collaborates with cross-functional teams on analytical method development, molecule characterization, testing, and analysis throughout various...
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Scientist, Analytical Development Specialist
4 weeks ago
Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...
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Analytical Chemist, Biotechnology Development
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Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...
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Development Director
1 week ago
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Director of Philanthropy and Development
2 weeks ago
Waltham, Massachusetts, United States Jewishsac Full timeJob Title: Director of PhilanthropyJewish Big Brothers Big Sisters of Greater Boston is seeking a highly skilled and experienced Director of Philanthropy to lead our Development Team and drive our fundraising efforts.About the Role:The Director of Philanthropy will be responsible for developing and implementing a comprehensive fundraising strategy, including...
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Scientist, Analytical Development
1 week ago
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mRNA Analytical Testing Associate I
3 weeks ago
Waltham, Massachusetts, United States Yoh Full timemRNA Analytical Testing Associate IYoh has a Long Term Opportunity for an mRNA Analytical Testing Associate I needed with Yoh Scientific's client located in Waltham, MA. This position is in the mRNA Analytical Sciences Group of a major pharmaceutical company, and requires a Bachelor's of Science degree and 2+ years of hands-on experience in a laboratory...
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Associate Director
4 days ago
Waltham, Massachusetts, United States GSK Full timeAbout the RoleGSK is seeking a highly skilled and experienced professional to lead our Diagnostics and Precision Medicine team. As Associate Director, you will be responsible for developing and implementing diagnostic strategies to support our clinical studies and product development.Key ResponsibilitiesDevelop and lead end-to-end diagnostic strategies to...
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Scientist II, Analytical Development Specialist
2 hours ago
Waltham, Massachusetts, United States AbbVie Full timeJob Title: Scientist II, Analytical DevelopmentJob SummaryAbsorbent and analytical expert sought to support method lifecycle activities at external laboratories for late-phase antibody-drug conjugate (ADC) development. Collaborate with cross-functional teams to enable filing and commercialization of ADC programs.Key ResponsibilitiesSupport validations,...
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Waltham, Massachusetts, United States Atlas Venture Full timeJob Title: Scientist, Analytical Development & Quality ControlAbout the Role:The Scientist, Analytical Development & Quality Control will be responsible for leading daily lab operations, supporting CMC process development, and collaborating with key stakeholders to define analytical capabilities required to manage Dyne's complex clinical supply chain.Key...
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Waltham, Massachusetts, United States Atlas Venture Full timeJob Title: Scientist, Analytical Development and Quality Control SpecialistJob Summary:We are seeking a highly skilled Scientist, Analytical Development and Quality Control Specialist to join our team at Dyne Therapeutics. As a key member of our analytical development team, you will be responsible for developing, optimizing, and qualifying analytical methods...
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Waltham, Massachusetts, United States Softworld Full timeAbout Softworlds Vita Global SciencesWe are a professional services company specializing in clinical data analytics solutions and functional outsourcing services for the life sciences industry. Our team excels in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD...
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Business Development Director for Life Sciences
2 weeks ago
Waltham, Massachusetts, United States Softworld Full timeAbout Softworlds Vita Global SciencesWe are a professional services company catering to the life sciences industry. Our expertise lies in offering clinical data analytics solutions and functional outsourcing services. Our team is well-versed in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming,...
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Waltham, Massachusetts, United States Softworld Full timeAbout Softworlds Vita Global SciencesWe are a professional services company specializing in the life sciences industry, offering clinical data analytics solutions and functional outsourcing services. Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and...
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Associate Director Statistical Programming
7 days ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Title: Associate Director, Statistical ProgrammingDeciphera Pharmaceuticals is seeking an experienced Associate Director, Statistical Programming to join our team. As a key member of our Clinical Development department, you will play a critical role in ensuring the timely and quality support for analysis and reporting of clinical trials.Key...
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Waltham, Massachusetts, United States Sobi Full timeJob SummaryWe are seeking an experienced Associate Director of Payer Strategy and Marketing to join our team at Sobi. This role will be responsible for developing and executing US market access strategies and tactics to support the successful launch and market evolution of our Immunology product.Key ResponsibilitiesDevelop comprehensive payer/market access...
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Waltham, Massachusetts, United States ElevateBio Full timeAbout the RoleElevateBio is a pioneering technology-driven company that's revolutionizing the field of cell and gene therapy. As an Associate Director of BaseCamp Business Development, you'll play a crucial role in identifying, engaging, and contracting long-term partnerships that align with our strategic goals and objectives.Key ResponsibilitiesProspect...
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Director of Early Discovery and Development
1 week ago
Waltham, Massachusetts, United States Scipher Medicine Full time{"title": "Director of Early Discovery and Development", "content": "Join Our Team as a Director of Early Discovery and DevelopmentWe are seeking a highly skilled and experienced Director of Early Discovery and Development to join our team at Scipher Medicine. As a key member of our discovery team, you will be responsible for leading the development of novel...